Companies and Patients React to PSE Restrictions

SEPTEMBER 01, 2006

Wendy K. Bodine, Assistant Editor

Pseudoephedrine (PSE) has been used for the relief of nasal and sinus congestion caused by the common cold, sinusitis, hay fever, and other respiratory ailments for many years. It is considered by many doctors, pharmacists, and patients to be one of the best decongestants on the market. Unfortunately, the Drug Enforcement Administration discovered that it can be used in the making of methamphetamine, a Schedule II controlled substance, for the illicit drug market.

Consequently, Congress took measures to make it harder to get PSE by passing the Methamphetamine Anti- Proliferation Act in 2000. Effective April 8, 2006, this act limited the threshold of PSE-containing products a person can purchase to 3.6 g of PSE per day and to 9 g per month, with each product package not to exceed 3 g.

By September 30, 2006, all OTC drugs containing PSE must be placed behind pharmacy counters or locked in cabinets, to control the amounts bought by consumers and to prevent shoplifting. Sellers must keep a logbook to record the names and addresses of customers who obtained PSE drugs, which specific products they bought, how much they bought, and the date and time of each transaction. Several pharmacies around the country have already fallen in line, much to the chagrin of their customers.

Some drug manufacturers are offering phenylephrine (PE) as an FDA-approved alternative to PSE, to help keep their names on the easy-to-reach OTC shelves. Once more commonly found in nasal sprays, PE is not restricted by the FDA, because it cannot be used in the making of methamphetamine but has a similar mechanism to PSE. The only major difference for patients is in the dosing schedule?they need to take PE more frequently than PSE.

McNeil Consumer Healthcare currently has 2 formulations for most of its seasonal allergy and cold products: one version containing PSE and one with PE. Pfizer also has a reformulation of its popular Sudafed line of products with PE (Sudafed PE) as a "convenient, on-the-shelf alternative" to its original. Wyeth Consumer Healthcare's line of Robitussin items offers several products that contain PE.

Laurie Wooding, vice president of global communications for Novartis, said that the company has not shipped any products containing PSE since October 2005. By the time this year's cold season hits, all of its OTC cold products will feature only PE.

Substitution is not always the answer, however. Many pharmacists have heard from customers who switched to PEcontaining products to avoid the hassle of getting PSE from behind the counter. These patients have returned with reports of noneffectiveness.

Steven Pray, RPh, PhD, professor of nonprescription products at Southwestern Oklahoma State University in Weatherford, said that most customers prefer PSE products because the drug lasts longer than PE. "People just want to take 1 pill a day," he said. "They tell me that PE doesn't work as well for them as PSE."

Dr. Pray also noted that he hoped pharmacists would use the repositioning of PSE as an opportunity to build a rapport with customers when they come to purchase PSE. He believes that customers can benefit from pharmacists' knowledge of OTC medicines to help them make the right choices for themselves. "It helps the pharmacist develop a relationship with?customers, and that's something the customer can't get buying [PSE] at the grocery or convenience store," he said.

Many companies, such as Schering-Plough HealthCare Products, are "always exploring ways to best serve their customers," according to company spokeswoman Julie Lux. In the case of Schering's product Claritin-D (loratadine/ PSE), serving customers sometimes means sticking with what works. Claritin- D is known for its effectiveness as an allday decongestant. Although company officials realize that this product will soon go behind the counter with the other PSE-containing medicines, they encourage customers to take the extra step to get the treatment they can trust to work for them. "Claritin-D is still safe and effective to provide long-lasting relief when used as directed," said Lux.